Investigation of Acceptable Dose of Mobilisation and Tactile Stimulation to Enhance Upper Limb Recovery After Stroke

NCT ID: NCT00360997

Last Updated: 2018-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-12-31

Brief Summary

The purpose of this study is to find which of three doses of mobilisation and tactile stimulation therapy, when given in addition to conventional UK physical therapy, has the most beneficial effect on enhancing motor recovery of the upper limb early after stroke.

Detailed Description

Background The scientific evidence indicates that upper limb motor recovery may be enhanced with the appropriate dose of afferent stimulation normally arising from functional activities. Even if the appropriate dose was known, people with severe paresis or paralysis would not be able to participate in functional training. For these people "mobilization and tactile stimulation" (MTS) therapy might enhance: upper limb recovery, and, changes in brain regions that can influence motor output.

Questions In stroke patients with paralysis or severe paresis which dose of MTS therapy a) produces the least adverse events; b) has the most beneficial effect on voluntary muscle contraction and functional ability. This study will also address: c) whether the magnitude of sensory/motor cortex activation prior to MTS can predict response to MTS; and, d) whether changes in sensory and/or motor cortex activation correlate with improvement.

Subjects (n=80) from two clinical centres with an anterior cerebral circulation stroke 8 to 84 days before recruitment, paresis or severe paralysis and no clinically important pain affecting the upper arm or shoulder after stroke.

Methods After baseline measures (Day 1) subjects will be randomised to a) no extra therapy; or one of three doses of MTS therapy for 14 consecutive working days, b) 30 minutes; c) 60 minutes; or, d) 120 minutes. All subjects will receive the conventional therapy normally provided within each centre. On Day 16, outcome measures will be made. The experimental intervention, MTS therapy will be individualised for each subject from a standardised schedule of techniques within treatment categories including: passive movements, massage; specific sensory input; and, functional movement. The measurement battery will be: a) efficacy, Motricity Index Arm Section and the Action Research Arm Test; b) adverse events, presence of upper limb pain and decrease in Motricity Index score; and c) Functional MRI (London subjects), T1 weighted anatomical images and T2* weighted MRI transverse echo-planar images undertaking these studies with both sensory and motor paradigms where feasible.

Analysis Analysis for efficacy and adverse events will be conducted using the Chi-squared test for trend or linear regression as appropriate. The results will be combined to determine the most appropriate dose of MTS. Imaging data will be processed using Statistical Parametric Mapping and then analysed statistically using a least mean squares fit of the model to the data to determine regions of significant activation for each session.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Behavioural

Conventional UK physical therapy (Con UK PT)

Group Type: OTHER

Conventional UK physical therapy

Intervention Type: BEHAVIORAL

Con UK PT + MTS

Con UK PT + 30/60 or 120 minutes MTS

Group Type: EXPERIMENTAL

Con UK PT + Mobilisation & tactile stimulation (MTS)

Intervention Type: PROCEDURE

Con UK PT + Mobilisation \& Tactile Stimulation (MTS) which is further randomised to 30, 60 or 120 mins/day

Interventions

Conventional UK physical therapy

Intervention Type: BEHAVIORAL

Con UK PT + Mobilisation & tactile stimulation (MTS)

Con UK PT + Mobilisation \& Tactile Stimulation (MTS) which is further randomised to 30, 60 or 120 mins/day

Intervention Type: PROCEDURE

Other Intervention Names

Con UK PT; Con UK PT + MTS

Eligibility Criteria

Inclusion Criteria

• Have suffered an infarct or haemorrhage in the anterior cerebral circulation, confirmed by neuroimaging, 8 to 84 days before recruitment
• Have a paralysed or severely paretic upper limb as measured by a score of 61/100 or less on the Motricity Index Arm Section17

Exclusion Criteria

• Clinically important pain affecting the upper arm or shoulder when recruited to this study
• Visible upper limb movement deficits attributable to pathology other than stroke
• Unable to follow a 1-stage command using their non-paretic upper limb (ie severe communication or other cognitive deficits precluding ability to participate in MTS).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St George's, University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valerie M Pomeroy, PhD

Role: STUDY_CHAIR

St George's, University of London

Locations

North Staffordshire Combined Healthcare NHS Trust

Stoke-on-Trent, Staffordshire, United Kingdom

St Thomas' Foundation Hospital NHS Trust

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

TSA 2005/03

Identifier Type: -

Identifier Source: org_study_id